MesaGreen Announces Progress
K9MGP Seizure Program
In July 2019, MesaGreen Pharmaceutical (MGP) entered into a research agreement with the University of Minnesota Schools of Veterinary Medicine and Pharmacy and the Mayo Clinic to evaluate the ability of compound K9MGP to produce a cessation of ongoing seizures in canines. The study consisted of evaluating the drug given both intravenously (IV) and intramuscularly (IM) in two dogs with either a history of seizures or who were currently on medication to present seizures. One of the animals had implanted electrodes in the skull, which allowed for monitoring brain wave activity, referred to as an electroencephalogram (EEG).
Research Study Initiated
In September 2019, a research study regarding compound K9MGP was initiated. Two doses of the drug 0.1 milligrams/Kilogram and 0.3 mg/Kg were administered IM into a muscle located adjacent to the spinal column towards the hind limbs. Two different needle lengths, 5/8 and 1 inch, were employed as well as two different needle thicknesses, 27 and 23 gauge, were tested. The higher dose was also administered by IV. As anticipated, the high dose of K9MGP resulted in plasma levels three times higher than the lower dose. This indicated linearity of a dose-response relationship. There were no differences in the plasma levels associated with the two different needle lengths or gauges. The drug produced the highest plasma level when given IV.
In October of 2019, the EEG activity was evaluated and compared to the plasma level data of compound K9MGP. The appearance of beta wave activity in the EEG is associated with a cessation of seizure activity. This was observed when the plasma levels of K9MGP reached and passed 50 nanograms/milliliter. The IM dose of 0.1 mg/Kg reached this level between 2-4 minutes following administration. The IM dose of 0.3 mg/Kg reached this level between 1-1.2 minutes following drug administration. The IV dose reached this level virtually instantaneously.
Research Study Expanded
In September of 2020, MGP expanded the study to include the IM administration of compound K9MGP given by an auto-injector simulator (AIS). This device rapidly injects the drug under pressure and is typically used to treat emergency situations. Examples would include administering naloxone to treat a narcotic overdose or giving epinephrine (EpiPen) to treat anaphylaxis. The device employed was designed by Oval Medical Technologies. The dose administered was 0.3 mg/Kg, and results compared to the data obtained with 0.3 mg/Kg given IM using the standard syringe with a 1 inch 23 gauge needle. The data obtained showed that the dose of K9MGP given by the AIS resulted in a plasma level of 50 ng/ml observed in 0.4-0.6 minutes following IM administration. This was significantly faster than observed with the same dose given using the standard manual injector. The conclusion of these results suggests that the administration of both 0.1 and 0.3 mg/Kg of K9MGP given IM via the AIS will result in immediate cessation of ongoing seizures in canines.
MesaGreen Shows Progress and Promise Moving Forward
With the final report now complete MGP in association with the University of Minnesota, the Mayo Clinic and Oval Medical Technologies are currently preparing two Abstracts of the research results to be presented at the December 2021 Annual Meeting of the American Epilepsy Society. Also, the team has begun writing a research manuscript for publication in a high-impact journal of veterinary medicine.
MGP’s product will fill a significant gap and an unmet need in canine health care. We met the challenges presented by the Covid-19 pandemic and completed our studies in 2020. The data generated in these studies provide the basis for pre-IANDA discussions with U.S. FDA’s Center for Veterinary Medicine. MGP anticipates engaging CVM in the early fall of 2021.